Computer System Validation Engineer

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our pany: One of Our Clients Job Description:Job Title: Computer System Validation EngineerLocation: Libertyville, IL 60048Duration: 12+ Months (Extendable)Pay Rate: $62.50hr on W2Must Have List:- Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.- Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment.- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices- Knowledge and experience in utilizing Change Management Applications i.e. ServiceNow, Infinity, Veeva, Valgenesis,- Experience in leading investigations and initiating deviations and Change Control activities.- Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.- Understanding of computer system validation and experience using IT service management platforms (QMS) to support incident, problem and change IT operational events (i.e. ServiceNow, Infinity).- Familiarity with DCS systems (i.e. Emerson DeltaV, Rockwell SCADA, ERP systems (i.e. SAP or Oracle), and Historians (i.e. OSIsoft PI).PURPOSE AND SCOPE OF POSITION:The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for development of and adherence to system governance procedures. The individual supports multiple IT projectssystems and ongoing work activities of moderate to high complexity.Reporting into the site Digital Plant organization the candidate will be primarily responsible for managing IT deviations, CAPAs, Investigations, Change Management, computer system validation in support of the vector manufacturing site.The candidate should have at least 5+ years of experience in pharmabiotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines. The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing systems development and support. DUTIES AND RESPONSIBILITIES:• Support the IT Quality & Compliance for the Cell Therapy Vector manufacturing site.• Take ownership of deviations, CAPAs and investigations involving the Manufacturing IT Systems.• Open and lead investigations, triage deviations, and ensure CAPAs are addressed and implemented per requirements.• Engage technical experts as needed to author and present change requests and author investigations write-ups.• Support Health Authority and internal audits.• Collaborate and support the other Site IT groups (Manufacturing IT Systems & MES, Operational Technology Systems & Automation, Enterprise Systems and Integration, IT Site Shared Services) to ensure we can correctly support the manufacturing site.• Gain proficiency in the IT Service Management platform ServiceNow to create and track service requests, incidents, requests, problems, etc.• Provide support for operationalizing the manufacturing and peripheral systems.• Responsible for Computer System Validation of localsite-based systems• Accountable for the continued compliance of IT systems, procedures and training for vector manufacturing and lab systems. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:• Ability to effectively communicate with both technical and non-technical team members.• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication• Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.• Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).• Strong technical and problem-solving skills and the ability to work independently.• Demonstrated success working in a high-performing, business results-driven environment.• Understanding of computer system validation.• Familiarity with MES systems (i.e. Emerson Syncade), DCS systems (i.e. Emerson DeltaV, ERP systems (i.e. SAP or Oracle), EBRs (i.e. InfoBatch) and Historians (i.e. OSIsoft PI).• Understanding of computer system validation (CSV). Education and Experience:• Bachelor's degree in an engineering or MIS discipline.• Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.• Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment.• Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.• Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE).Awards and Accolades: America's Most Honored Businesses (Top 10%)Awarded by USPAAC for Fastest Growing Business in the US12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)Fastest 50 by NJ Biz (2020, 2019, 2020)INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)Top 100 by Dallas Business Journal (2020 and 2019)Proven Supplier of the Year by Workforce Logiq (2020 and 2019)2019 Spirit of Alliance Award by Agile12018 Best of the Best Platinum Award by Agile12018 TechServe Alliance Excellence Awards Winner2017 Best of the Best Gold Award by Agile1(Act1 Group)Regards,Kajal SinghSenior IT Recruiter (Pharma and Life Sciences)Net2Source Inc.Global HQ Address -270 Davidson Ave, Suite 704, Somerset, NJ 08873, USAOffice: (201) 340-8700 x 980 | Cell: (201) 777-4217 | Fax: (201) 221-8131| Email:

Created: 2025-02-21